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Report for Clinical Trial NCT03381066

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase III, Randomized, Multi-center Study to Determine the Efficacy of the Intercalating Combination Treatment of Chemotherapy and Gefitinib or Chemotherapy as Adjuvant Treatment in NSCLC With Common EGFR Mutations.

This study aims to compare the efficacy of intercalating chemotherapy (gefitinib and pemetrexed/cisplatin) and chemotherapy (navelbine/cisplatin) in completely resected NSCLC with common EGFR mutations.

NCT03381066 Completely Resected NSCLC With Common EGFR Mutations
MeSH: Carcinoma, Non-Small-Cell Lung
HPO: Non-small cell lung carcinoma

2 Interventions

Name: gefitinib, pemetrexed,cisplatin

Description: Intercalation phase (Duration: 3weeks x 4 cycles = 12 weeks) Pemetrexed 500mg/m2 D1, Cisplatin 75mg/m2 D1, Gefitinib 250mg D5-18, every 3week Maintenance phase (Duration: 1 year) Gefitinib 250mg D1-2

Type: Drug

Intercalating arm

Name: Vinorelbine, cisplatin

Description: Duration: 3wks x 4 cycles = 12 weeks Vinorelbine 25mg/m2 D1,8, Cisplatin 75mg/m2 D1 q3week

Type: Drug

chemotherapy alone arm


Primary Outcomes

Description: Time from the randomization to recurrence or any cause of death.

Measure: disease-free survival

Time: 5 years

Secondary Outcomes

Description: Time from the randomization to death of any cause

Measure: Overall survival

Time: 5 year

Measure: Number of participants with treatment-related adverse events as assessed by CTCAE4.0

Time: 5 years

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 L858R

Inclusion Criteria: 1. Completely resected non-squamous cell NSCLC with stage IIa to IIIb (excluding N3) according to Version 8 of the IASLC Staging Manual in Thoracic Oncology 2. Tumors with common EGFR mutations (19del or L858R) 3. Adequate oran function Exclusion Criteria: 1. Patients who were exposed to the chemotherapy or EGFR TKIs for NSCLC. --- L858R ---

2. Patients with interstitial lung disease Inclusion Criteria: 1. Completely resected non-squamous cell NSCLC with stage IIa to IIIb (excluding N3) according to Version 8 of the IASLC Staging Manual in Thoracic Oncology 2. Tumors with common EGFR mutations (19del or L858R) 3. Adequate oran function Exclusion Criteria: 1. Patients who were exposed to the chemotherapy or EGFR TKIs for NSCLC. --- L858R ---



HPO Nodes


HPO:
Non-small cell lung carcinoma
Genes 3
TP53 TP53 BAP1